Navigation Links
Johnson & Johnson Violated FDA Order to Halt Sales of Transvaginal Mesh
Date:6/27/2012

(PRWEB) June 27, 2012

In complete disregard of an order by the U.S. Food and Drug Administration (FDA) to stop marketing the Gynecare Prolift vaginal mesh implant, Johnson and Johnson (J&J) continued to sell the product for nine additional months. According to court records, in a letter dated August 24, 2007, the FDA advised J&J to halt the sales of the Gynecare Prolift until such time the agency determined whether the device was the “substantially equivalent” to other mesh products on the market. The letter clearly stated, “You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food Drug and Cosmetic Act.” Despite this warning, J&J continued to sell the mesh product until the FDA cleared the device in May 2008 after months of negotiations with J&J.

J&J initially began selling the Prolift in 2005. It failed to apply for application and approval from the FDA because it unilaterally determined its product was substantially similar to the Gynemesh product already approved by the FDA, according to Matthew Johnson, J&J spokesman. The FDA disagreed and required a new application be submitted. The company’s failure to initially heed FDA orders could prove costly. Currently there are more than 1,400 lawsuits pending against J&J by women injure
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Research shows efficacy of treatment model developed at Women & Infants
2. Soy-based S-equol supplement reduces hot flash frequency, muscle & joint pain in US women
3. Vendors in Nevada, Michigan, & Illinois to be Featured on the PartyPOP.com Online Network
4. Beef & Pork Wholesaling in the US Industry Market Research Report Now Available from IBISWorld
5. The Tennessee Car Accident Lawyers at Michael D. Ponce & Associates Alert Public of CDC Survey Revealing Majority of High School Seniors Admitting to Texting Behind Wheel
6. Alex Galindo, Attorney and Partner at Curd, Galindo & Smith, LLP, Court Wins Against the County of Riverside's Motion to Dismiss Medical Malpractice Case
7. Play & Park Structures Included in New Play for All Abilities Playground
8. Gum Disease, HPV May Play Role in Head & Neck Cancers
9. New Treatments Emerging from Immune and Inflammatory Disease R&D Pipelines
10. Version 2.0 of Award-Winning Proloquo2Go App for iPhone, iPad & iPod touch Speeds Up Communication, Adds New Voices and Customization Options
11. Ear, Nose & Throat Journal publishes research on breakthrough treatment for tonsil stones
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/22/2014)... high school sport in the United States with 1 ... in the Center for Injury Research and Policy at ... describe the occurrence and distribution patterns of basketball-related injuries ... training setting among adolescents and teens. , The study, ... , examined data relating to adolescents 13-19 years of ...
(Date:4/22/2014)... decades researchers have characterized a set of clock genes ... all types of species, from flies to humans. Over ... surmise there are more. A team from the Perelman ... if big-data approaches could find them. , To ... PhD, professor of Pharmacology and first author Ron Anafi, ...
(Date:4/22/2014)... all lung cancers are small cell lung cancers ... to chemotherapy. However, researchers at Virginia Commonwealth University ... the mechanisms leading to this resistance that may ... primarily by mediating B-cell lymphoma 2 (Bcl-2) family ... Depending on their function, this family of proteins ...
(Date:4/22/2014)... 2014) The International Communication Association will hold ... Washington. The theme of the 2014 conference will ... networked and digital society. , Featuring over 2,300 ... 2,200 Communication scholars representing over 40 countries, the ... conference in the world. This year,s conference features ...
(Date:4/22/2014)... . , Reactive ... mode of action is complex: In low concentrations they ... at high concentrations they can cause "oxidative stress", which ... signaling unfolds in single cells and organelles in real-time, ... by the teams of LMU Professor Martin Kerschensteiner and ...
Breaking Medicine News(10 mins):Health News:New study finds 2.5 million basketball injuries to high school athletes in 6 seasons 2Health News:New study finds 2.5 million basketball injuries to high school athletes in 6 seasons 3Health News:Bioinformatics profiling identifies a new mammalian clock gene 2Health News:Scientists pinpoint protein that could improve small cell lung cancer therapies 2Health News:International Communication Association to hold Annual Conference in Seattle, Washington 2Health News:Neuroimaging: Live from inside the cell 2
... WOODS HOLE, MASummer on Cape Cod is synonymous with ... scientists at the MBL (Marine Biological Laboratory). For more ... each summer from around the world to immerse themselves ... of marine organisms available for study and the wealth ...
... like children brings out more resistance, study found , , ... often become upset and even act out when nurses ... them, a new,study shows. , Researchers who taped the ... Alzheimer,s found that the residents often became more agitated ...
... Counseling LLC launches new website offering convenient http://www.terrimilen.com [Online ... in the comfort of their own home or office. , ... ... effort to provide clients with an alternative to traditional therapy which ...
... better quality of life , , SATURDAY, July 26 (HealthDay News) ... on the body may one day be to dialysis patients ... automated, wearable artificial kidney (AWAK) works better than conventional dialysis, ... Clinical and Experimental Nephrology . , "What,s really new about ...
... & Olsen LLP has filed a,class action lawsuit against ... and certain of its officers in the U.S. District,Court ... all persons or,entities who purchased the common stock ArthroCare ... Stock Purchaser Class Period") and all,persons or entities who ...
... of Phoenix employees at 62 campuses, 43 affiliated sites open ... cupboards, hearts to help feed nation,s hungry, ... the,nation,s hungry as employees at University of Phoenix, 62 campuses, ... food items and monetary donations to provide more,than 68,000 meals. ...
Cached Medicine News:Health News:LabBits: A media tip sheet from the MBL in Woods Hole 2Health News:LabBits: A media tip sheet from the MBL in Woods Hole 3Health News:LabBits: A media tip sheet from the MBL in Woods Hole 4Health News:Alzheimer's Patients React Poorly to 'Elderspeak' 2Health News:Alzheimer's Patients React Poorly to 'Elderspeak' 3Health News:Online Counseling and Life Coaching Practice Launches New Website 2Health News:Klafter & Olsen LLP Announces That It Has Filed a Class Action Lawsuit Against ArthroCare Corporation on Behalf of Common Stock Holders and Certain Traders in ArthroCare Options 2Health News:Klafter & Olsen LLP Announces That It Has Filed a Class Action Lawsuit Against ArthroCare Corporation on Behalf of Common Stock Holders and Certain Traders in ArthroCare Options 3Health News:Hunger Is Happening National Food Drive a Huge Success -- Donations Will Serve 68,000 Meals 2
(Date:1/15/2014)...  Zafgen, Inc., a leading biopharmaceutical company dedicated to ... today announced initial results from its Phase 2a ... aminopeptidase 2 (MetAP2), in patients with Prader-Willi syndrome ... results showed improvements in body weight, hunger-related behaviors, ...
(Date:1/14/2014)... , Jan. 14, 2014 HeartWare International, Inc ... of less invasive, miniaturized circulatory support technologies that are ... that it expects revenues for the fourth quarter of ... 2013 revenues to approximately $208 million. "Our ...
(Date:1/14/2014)... InformEx, North America,s leading business partnering ... the 30 th edition of its annual conference at ... January 21-24. (Logo: http://photos.prnewswire.com/prnh/20131028/NY05330LOGO-a ) ... and specialty chemical companies will take part in the conference, ...
Breaking Medicine Technology:Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 2Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 3Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome 4HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 2HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 3HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 4Media Advisory: InformEx 2014 Events & Speaker Lineup for 30th Edition Conference in Miami Beach 2
... 1 Graymark Healthcare , Inc. (Nasdaq: ... which Walgreen Co. will acquire substantially all of the ... Graymark Healthcare . Graymark expects to realize a total ... AR, expenses and proceeds from the liquidation of remaining ...
... Laboratoires Thea Acquires the Mydriasert(R) ophthalmic Insert From Carl Zeiss Meditec -- CLERMONT-FERRAND, France, September 1, ... ... if (typeof(lpUnit)==,undefined,) var lpUnit=,PRN,; --> ... var shortURL = ""; BitlyCB.alertResponse = function(data) { var s = ,; var first_result; // ...
Cached Medicine Technology:Graymark Healthcare Agrees to Sell Pharmacy Division to Walgreens Creating Pure Play Sleep Apnea Company 2Graymark Healthcare Agrees to Sell Pharmacy Division to Walgreens Creating Pure Play Sleep Apnea Company 3French Laboratoires Thea Acquires the Mydriasert(R) ophthalmic Insert From Carl Zeiss Meditec 2French Laboratoires Thea Acquires the Mydriasert(R) ophthalmic Insert From Carl Zeiss Meditec 3French Laboratoires Thea Acquires the Mydriasert(R) ophthalmic Insert From Carl Zeiss Meditec 4French Laboratoires Thea Acquires the Mydriasert(R) ophthalmic Insert From Carl Zeiss Meditec 5French Laboratoires Thea Acquires the Mydriasert(R) ophthalmic Insert From Carl Zeiss Meditec 6French Laboratoires Thea Acquires the Mydriasert(R) ophthalmic Insert From Carl Zeiss Meditec 7
New - Color Coded Berman Airways. A simple idea makes size identification easier for you., ,Premium upgrade without a premium price. Color Coded Berman airways are latex-free., ,Plastic. Single use...
... Wire Reinforced Endotracheal Tube Kits (silicone) ... individually and includes a SidePort™ AutoControl™ ... and 15 mm ISO connector., ... safety by helping to ensure an ...
... uncuffed endotracheal tubes are available ... in standard or precut lengths., ... pediatric uncuffed endotracheal tubes are ... with a radiopaque blue line ...
Portex® Blue Line® cuffed endotracheal tubes come in a wide selection of sizes, each with a standard 15 mm ISO connector., ,Portex® Blue Line® endotracheal tubes are recognized world...
Medicine Products: